30-to-90 Day Challenge: Effects of Alcohol Cessation on Health Outcomes

Conditions:Cognitive Studies, Infectious Disease, HIV / AIDS, HIV / AIDS, Psychiatric, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Psychiatry / Psychology
Age Range:50 - 75
Start Date:December 11, 2017
End Date:December 2020
Contact:Robert Cook, MD, MPH

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Effects of Experimentally-induced Reductions in Alcohol Consumption on Brain Cognitive and Clinical Outcomes, and Motivation for Changing Drinking in Older Persons With HIV Infection

The objective for this project is to determine whether how certain behavioral and health
functions change in persons with heavy drinking when they stop (or reduce) drinking for 30
days, and whether changes continue for up to 90 days. The study will also identify barriers
and facilitators related to drinking reduction. The project will focus on clinical
comorbidities including HIV disease control, cognitive and brain function, liver
abnormalities, and chronic inflammation. The study teams propose to enroll 140 HIV+ and 40
HIV- adults with heavy drinking, and then use Contingency Management (CM) with financial
incentives to encourage participants to maximally reduce alcohol consumption for 30 days.
Participants will be required to wear an ankle biosensor (SCRAM monitor) at all times, which
is used to monitor participants' drinking behavior. At 30 days, participants will complete a
full day of follow-up, including cognitive testing, neuroimaging, blood testing, liver
Fibroscan, and questionnaires. Many participants will also provide a stool sample for gut
microbiome assessment at each time point. At 30 days, participants will participate in a
motivational interview to discuss perceived benefits and obstacles to drinking reduction, and
most participants will continue CM to 90 days (but can opt out at this point). Participants
will complete another full-day assessment at 90 days, at which point persons may choose to
drink or not on their own (no more CM). A final assessment will be conducted at 12 months.
This A-B-A design will enable us to clearly identify whether alcohol effects on cognition and
brain function are reversible in the context of HIV, and analyze specific cerebral and
systemic pathophysiological factors contributing to these effects. The inclusion of HIV-
adults will enable subgroup comparisons of alcohol reduction effects in the context of HIV
vs. no-HIV. These HIV-negative participants will be recruited from the same settings as our
HIV+ participants, and will include a similar proportion by age, race, and gender as the HIV+
participants. The study team will use information from the MI data and our other assessments
to elucidate factors that predict both short term (during CM) and long-term (1-year) alcohol
reductions, and study how changes in alcohol consumption affect important HIV clinical
outcomes that will be monitored over time.

This proposed study continues a line of research by Doctors Cohen, Cook, Kahler, and
colleagues on heavy alcohol use, HIV-associated brain dysfunction, and long-term HIV
outcomes. The study will build on our past findings to determine the extent to which marked
reductions in alcohol consumption at 30 days and again at 90 days via contingency management
(CM) improves cognitive-behavioral performance, underlying brain functions and
pathophysiology, and HIV-associated health outcomes. This feature in itself is a novel
contribution and has rarely been done, but more importantly, it reflects the mission of the
collaboration to develop actionable data on clinical trajectories in HIV infected heavy
drinkers over age 50 that will instill high confidence in guiding next therapeutic steps. The
study team will obtain a better understanding of how persons with HIV stop drinking, and what
factors influence long-term drinking changes. These important clinical and scientific
questions need resolution for successful treatment and management of HIV+ adults. This study
is motivated by evidence that HIV-associated neurocognitive dysfunction continues despite
effective combined anti-retroviral therapies (cART). Even mild cognitive impairments have
detrimental functional effects and health outcomes that worsen as HIV+ people age. Heavy
alcohol consumption is common among HIV+ adults, and contributes to functional brain
disturbances directly or indirectly via systemic metabolic or inflammatory disturbances.
However, our past findings indicate that current alcohol use is more strongly associated with
cognitive and brain dysfunction among HIV+ adults than lifetime consumption; and that adverse
brain effects occur primarily with heavy drinking. Our overarching hypothesis is that the
impact of ongoing heavy alcohol use on the brain and cognition may be reversible, providing a
strong impetus for the proposed study. The study team will conduct our research in Florida,
which has the highest number of new HIV infections in the US, as well as an increasingly
diverse population with HIV+, 50% of whom are now aged 50 years or over in the state.

Our research will seek to modify alcohol consumption by using contingency management (CM) and
measure for changes in brain pathophysiology and function, as well as changes in systemic
inflammation, and gut and liver pathologies which are hypothesized pathways by which alcohol
may increase brain dysfunction. The study team will also measure neurocognitive functioning
related to learning, attention-executive functions, working memory, and processing speed,
domains in which HIV+ persons experience persistent impairment. the study team will use
Motivational Interviewing (MI) to learn more about how persons with and without HIV reduce
drinking, what factors are associated with long-term drinking changes, and how these drinking
changes influence HIV clinical health behavior and outcomes. If the impact of alcohol on
systemic and cerebral inflammation is temporary, then reducing or eliminating alcohol
consumption could dramatically improve cognitive function and indices of brain health, even
among people who have consumed alcohol for many years in the past. Our research will directly
test hypotheses that ongoing heavy alcohol consumption is associated with brain
pathophysiology and inflammation that impairs both functioning and cognitive processing, and
that the inflammation and its sequelae are reversible in most HIV+ persons with alcohol
cessation. The proposed sample will be 140 adults with HIV infection and 40 adults without
HIV infection (at least 25% female; age >50 years). Participants will be recruited from heavy
drinkers (>=14 drinks/week women, >=21 drinks/week men) with HIV infection identified from
our ongoing Florida Cohort. HIV- participants will be recruited from community medical
clinics where flyers will be posted.

Inclusion Criteria:

1. Men and women;

2. Age: 50-75 yrs.;

3. 140 participants will have confirmed HIV (confirmed via baseline bloodwork) and 40
participants will be HIV negative

4. English speaking (will have protocol ready in Spanish in 2017);

5. Physically mobile;

6. Willing to participate in CM to reduce alcohol consumption, and to wear the alcohol
biosensor for at least 30 days. All participants will be current, heavy drinkers (>=14
drinks/week women, >=21 drinks/week men), confirmed by baseline timeline follow-back,
and by having evidence of at least 3 drinking episodes on the alcohol biosensor prior
to baseline). Must blow a "zero" on breathalyzer at time of informed consent

Exclusion Criteria:

1. Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).

2. Evidence of dementia (MOCA < 17).

3. Past opportunistic brain infection

4. Major psychiatric illness (schizophrenia, intractable affective disorder, current
substance dependence diagnosis).

5. Current major psychiatric disturbance, including severe major depression.

6. Unstable medical conditions (e.g., cancer).

7. MRI contraindications (e.g., pregnancy, severe claustrophobia, metal implants).

8. Physical impairment precluding motor response or lying still.

9. Significant history of alcohol withdrawal as indicated by an Alcohol Withdrawal
Symptom Checklist score ≥ 23 (within past year).

10. Unable to correctly answer a set of questions that demonstrate understanding of key
aspects of the study, including the voluntary nature of the study, the purpose of the
study, what participants are being asked to do as part of the study, and what are the
risks related to participating in the study.
We found this trial at
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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